BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2925405 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01640
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 6, 2013
    Manufacturer
    BAXTER HEATHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THIS COMPLAINT FOR PERITONITIS -NO MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THE LOT NUMBER WAS UNKNOWN. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A CLINICAL STUDY FROM A HEALTHCARE PROFESSIONAL FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 THERAPY FOR PERITONEAL DIALYSIS. PER THE CLINICAL STUDY, THE SUBJECT HAD SUFFERED FROM DIARRHEA FOR OVER ONE WEEK AND THEN BEGAN TO HAVE A FEVER OF 38 DEGREES CELSIUS, NAUSEA, AND VOMITING. ANTIBIOTIC TREATMENT WAS NOT EFFECTIVE, SO THE SUBJECT WAS ADMITTED TO THE OUTPATIENT INFECTION DEPARTMENT OF THE HOSPITAL ON (B)(6) 2012. ON (B)(6) 2012, THE SUBJECT EXPERIENCED BACILLARY DYSENTERY. BEGINNING ON (B)(6) 2012, THE SUBJECT WAS TREATED WITH MONTMORILLONITE POWDER, 3 GRAMS BY MOUTH (PO) THREE TIMES DAILY (TID), AND BERBERINE HYDROCHLORIDE, 0.3 GRAMS PO TID, FOR THE BACILLARY DYSENTERY UNTIL (B)(6) 2012. BEGINNING ON (B)(6) 2012, THE SUBJECT WAS TREATED FOR THE BACILLARY DYSENTERY WITH LEVOFLOXACIN HYDROCHLORIDE INJECTION, 0.3GRAMS IV TWICE DAILY (BID), UNTIL (B)(6) 2012. BEGINNING ON (B)(6) 2012, THE SUBJECT RECEIVED CEFOPERAZONE SODIUM AND SULBACTAM SODIUM INJECTION, 3 GRAMS IV BID, FOR THE BACILLARY DYSENTERY AND, LATER, PERITONITIS UNTIL (B)(6) 2012. THE SUBJECT EXPERIENCED PERITONITIS ON (B)(6) 2012 (AFTER HOSPITAL ADMISSION), MANIFESTED BY CLOUDY DIALYSATE WITHOUT ABDOMINAL PAIN. ON (B)(6) 2012, THE SUBJECT BEGAN TREATMENT WITH CEFOPERAZONE SODIUM AND SULBACTAM SODIUM INJECTION, 1.5 GRAMS DAILY INTRA-PERITONEALLY (IP), AND CEFAZOLIN, 1 GRAM IP DAILY, FOR THE PERITONITIS UNTIL (B)(6) 2012. ON (B)(6) 2012, THE PATIENT RECOVERED FROM THE BACILLARY DYSENTERY AND PERITONITIS. ON (B)(6) 2012, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. THE HEALTHCARE PROFESSIONAL ASSESSED THE EVENTS AS MILD IN SEVERITY AND MODERATE IN INTENSITY. THE BACILLARY DYSENTERY AND PERITONITIS WERE NOT ASSOCIATED WITH BAXTER PRODUCTS. THE EVENT WAS NOT DUE TO A TRIAL PROCEDURE BUT THE HEALTHCARE PROFESSIONAL DID NOT PROVIDE AN ALTERNATIVE ETIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31160 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEATHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R ADALAT| AROTINOL| ERYTHROPOIETIN| INSULIN ASPARTAT| POLYSACCHARIDE IRON COMPLEX| DIANEAL PD2